NCT04728204

Brief Summary

This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (CBT) for depressed elderly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

January 15, 2021

Last Update Submit

September 22, 2025

Conditions

Keywords

DepressionInternet-based cognitive behaviour therapyElderlyeHealth

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire (PHQ-9)

    Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 9 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

    Pre-treatment, week 8, 3, 12 and 24 months post-treatment

  • Geriatric Depression Scale (GDS)

    Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 15 questions that have to be responded 'Yes' or 'No'. Higher score indicates more severe symptoms.

    Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Secondary Outcomes (2)

  • Generalized Anxiety Disorder-7 (GAD-7)

    Pre-treatment, week 8, 3, 12 and 24 months post-treatment

  • The World Health Organisation- Five Well-Being Index (WHO-5)

    Pre-treatment, week 8, 3, 12 and 24 months post-treatment

Other Outcomes (1)

  • The Alcohol Use Disorders Identification Test (AUDIT)

    Pre-treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

8 module, 8 week long internet-based intervention for reducing burden of depression

Behavioral: Depresijos terapija

Control group

NO INTERVENTION

Participants randomized to the control group will be instructed to wait until the intervention group finishes the treatment and that they will be able to use the same intervention afterwards.

Interventions

Intervention is based on the principles of cognitive behavioral therapy and culturally adapted to elderly Lithuanian population. The main purpose of the intervention is to reduce the symptoms of depression and increase psychological well-being. Intervention contains psychoeducation, examples, exercises and consultation with a psychologist.

Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • depressive symptoms
  • have access to a computer/tablet/smartphone and to the internet
  • have good knowledge of the Lithuanian language

You may not qualify if:

  • alcohol addiction
  • presently in any other psychological treatment
  • severe depression
  • suicidal ideation
  • significant change in psychiatric medication (during last 6 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, Lithuania, LT-01513, Lithuania

Location

Related Publications (1)

  • Eimontas J, Pakalniskiene V, Biliunaite I, Andersson G. A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial. Trials. 2021 Dec 16;22(1):925. doi: 10.1186/s13063-021-05903-4.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jonas Eimontas, PhD

    Vilnius University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either control or intervention group. Participants in the control group will receive the same treatment after the intervention group is finished with the treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Senior Research Fellow

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 28, 2021

Study Start

January 28, 2021

Primary Completion

July 15, 2021

Study Completion

October 6, 2022

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations